| Reagan-Udall Foundation

Read more about Oblato, Inc.

Family physician Mitchell A. Kaminski, MD, MBA, was still awash in feelings of joy and relief at recently being vaccinated against COVID-19 when a patient's comments stopped him cold. The patient, a middle-aged man with several comorbidities, had just declined the pneumonia vaccine – and he added, without prompting, that he wouldn't be getting the COVID vaccine either. This patient had heard getting vaccinated could kill him.

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Read more about How to Talk to Patients Reluctant to Get a COVID-19 Vaccine - Medscape

Moderna emerged as an early leader in the race for a vaccine to stop Covid-19 in its tracks. The Cambridge, Massachusetts-based biotech bounded through development of one of the world’s first mRNA vaccines, but in September — when the pandemic was claiming upwards of 700 lives a day in the US — they took a step back.

The company did something not many (if any) biotechs have ever done: At the urging of the US government, they slowed Phase III enrollment to recruit more participants from minority groups.

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Read more about 'Part of recovery is awareness': Pandemic casts harsh spotlight on industry-wide lack of diversity in clinical trials -Endpoints

The COVID-19 pandemic remains a significant global threat. However, despite urgent need, there remains uncertainty surrounding best practices for pharmaceutical interventions to treat COVID-19. In particular, conflicting evidence has emerged surrounding the use of hydroxychloroquine and azithromycin, alone or in combination, for COVID-19. The COVID-19 Evidence Accelerator convened by the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, assembled experts from the health systems research, regulatory science, data science, and epidemiology to participate in a large parallel analysis of different data sets to further explore the effectiveness of these treatments.

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Read more about COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients

Susan Winckler, CEO of the Reagan-Udall Foundation for the Food and Drug Administration, is the American Pharmacists Association Foundation’s 2021 recipient of the Jacob W. Miller Award. The award recognizes individuals who help to advance the Foundation’s mission through their involvement and leadership in longstanding programs and new initiatives.

Established in 2000, the award honors Jacob W. Miller who held positions in state and national pharmacy organizations and was APhA Foundation president from 1990-2000.

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Read more about APhA Foundation names 2021 Jacob W. Miller Award recipient - Drug Store News

Read more about Pharvaris

FDA and the Reagan-Udall Foundation for the FDA held a virtual public meeting on the potential medication error risks with investigational drug container labels. We solicited input from stakeholders (e.g., sponsors, investigators, clinical sites, entities that supply or label investigational drugs, and study participants) on the risk of medication errors related to the content and format of information on investigational drug container labels, the prevalence and nature of medication errors, and practices that might minimize the potential for such errors.

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Read more about Potential Medication Error Risks With Investigational Drug Container Labels

Read more about Exelixis, Inc.

It’s early 2021 in the Northeast and a major snowstorm has just been announced. Schools will be closed for the next two days. Kids will be home and likely, quite happy to be off from school. Under normal circumstances, parents would be home too, trying to work and probably attempting to create some sort of scheduled structure for the kids.

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